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510(k) Data Aggregation
(71 days)
This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.
This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The device features a "one-piece" design of needle hub and protective sheath with a living hinge. The needle cannula is permanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation, i.e. when the sheath is oriented to the right, the bevel is in the "up position". After the procedure is completed, the needle is pressed into the sheath using a onehanded technique. As the needle enters the protective sheath, the needle is engaged under the hook and contained within the sheath. The device is then discarded into a sharps container.
The provided document is a 510(k) summary for a hypodermic needle with an attached safety device, seeking substantial equivalence to predicate devices. It focuses on the safety mechanism to prevent needle sticks after use.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Efficacy (Needle Stick Prevention) | "A simulated clinical use study was conducted which confirmed that the device could be used effectively with the needle shielded inside the protection device after use." |
| Conformance to ISO 594-1:1986(E) (Conical fittings with a 6% taper for syringes, needles, and other medical equipment - Part 1: General requirements) | Declared conformance to this standard. |
| Conformance to ISO 594-2:1998(E) (Conical fittings with a 6% taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings) | Declared conformance to this standard. |
| Conformance to ISO 7864:1993(E) (Sterile hypodermic needles for single use) | Declared conformance to this standard. |
| Functional Equivalence (Intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe) | This is the stated indication for use and implied to be met. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "A simulated clinical use study was conducted." However, it does not provide a specific sample size for this study or details regarding the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications to establish ground truth for the simulated clinical use study.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted or reported. The study described is a "simulated clinical use study" focused on the device's functionality rather than comparing human reader performance with and without AI assistance.
6. If a Standalone Study (Algorithm only without human-in-the-loop performance) Was Done
This device is a physical medical device (hypodermic needle with a safety mechanism), not an AI algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply. The "simulated clinical use study" refers to the device's physical function.
7. The Type of Ground Truth Used
The "simulated clinical use study" implies that the ground truth was based on direct observation of the device's physical function (i.e., whether the needle was effectively shielded after use) rather than expert consensus on images, pathology, or outcomes data. It's a performance-based assessment.
8. The Sample Size for the Training Set
The document does not mention any training set as this is a physical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, the method for establishing its ground truth is not applicable.
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